Genmab — Juli 2018
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Our third late-stage clinical program in our pipeline is tisotumab vedotin, or TV, which we are co-developing with Genmab. We recently treated the first patient with TV in the pivotal Phase 2 single-arm monotherapy trial called innovaTV 204 in women with second or third line cervical cancer. Target enrollment is approximately 100 patients and the primary endpoint is ORR. The trial is intended to support regulatory submission under the FDA's accelerated approval pathway
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We and Genmab are also planning a trial of TV in combination with other agents with a goal of understanding TV's potential in earlier lines of cervical cancer. This study will likely start in 2019, initially in the second line setting with the goal of moving into first line. Lastly, another recent accomplishment with the TV program is that we treated the first patient in a Phase 2 basket trial.
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This trial is enrolling four solid tumor types that highly expressed tissue factor including pancreatic, head and neck, colorectal, and head and neck, colorectal and non-small cell lung cancer. This study is designed to inform a potentially expanded development program of TV.
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and of interest on ADC:
Our ADC collaborators are also making substantial progress with programs using our technology, underscoring the growing importance of ADCs in the treatment of cancer. An example of this was yesterday during the GSK Q2 results and R&D update where they highlighted their BCMA ADC in multiple myeloma, which utilizes our technology. GSK presented a broad development strategy, including several pivotal trials with this ADC as monotherapy and in combination regimens. -
De anonyme for solgt godt her fra morgenen. Mon de har opsnuset noget inden markedet?
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Får
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Hvis det er tommel ned, så ville vi nok se en noget mere dramatisk volumen
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efter luk
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JV> Dagen er jo ikke slut endnu. Håber dog du har ret.
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Dagen inden solide tumorer failede, så vi samme mønster. Der tog salget til om eftermiddagen.
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der var denne dag offentliggjort en negativ Azerra nyhed, så kan ikke sammenlignes
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NN går også ned - mon ikke blot det er en lille smule svær dag for biotek. Det er jo set mange gange før.
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Ved mulig godkendelse efter luk i dag, hvor meget tror I det vil give på kursen på mandag?
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Det er Ikke godkendelse i dag. Det er “kun” indstillingen til godkendelseskommiteen, vi får i dag. Godkendelse kommer max 67 dage efter. Vær ops på at en negativ anbefaling ikke betyder afvisning. Men vi skulle gerne have alle 12 medlemmer på vores side
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